Dexamethasone Intravitreal Implant for the Treatment of Macular Edema and Uveitis: A Comprehensive Narrative Review

Figures & data

Figure 1 Ultra-wide field image showing dexamethasone implant in the inferior vitreous in a patient with lasered proliferative diabetic retinopathy and recurrent macular edema.

Table 1 Summary of Studies of DEX Implant in RVO with Macular Edema

Study (Year)	Design	n	Intervention	Outcome Measure(s)	Time Point(s)	Results	Comments
Kuppermann et al. (2007)^Citation25	Phase 2, six-month, sham-controlled RCT, persistent macular edema, various etiologies	315	Single injection of DEX implant (350 mcg or 700 mcg) versus sham	≥10 letter BCVA gain	Day 90	35% (700 mcg), 24% (350 mcg) and 13% sham gained ≥ 10 letters	11% IOP increase ≥10 mm Hg Similar result in DME, RVO, uveitis, and Irvine Gass syndrome
Haller et al. (2010) GENEVA Study Group^Citation26	Phase 3, six-month, sham-controlled RCT, RVO with ME	1267	Single injection of DEX implant (350 mcg or 700 mcg) versus sham	≥ 15 letter BCVA gain	Various time points. Peak benefit at day 60	29% gainers at day 60, same for both doses. No difference from sham at 180	IOP ≥25 mm Hg in 16% at day 60 for both doses. Returned to baseline by day 180
Haller et al. (2011)^Citation27	Six-month open label extension of GENEVA trial	1256	Single DEX implant 0.7 mg at day 180 if indicated (n=997)	≥ 15 letter BCVA gain	Day 60	32% gainers after second injection (30% after first)	≥10 mm Hg IOP elevation in 12.6% after first, and 15.4 after the second. 30% showed cataract progression after two injections
Li et al. (2018)^Citation30	Phase 3, six-month, sham-controlled RCT followed by two month open-label extension for eyes with ME from RVO	DEX 129, sham 130	Single injection of 0.7 mg DEX implant versus sham. DEX implant at 6 months for pre-specified criteria	≥ 15 letter BCVA gain	Various time points. Peak effect at day 60	VA gainers. 35% DEX versus 12% sham. Mean change +10.6 letters (DEX) versus +1.7 letters (sham)	Duration of benefit 3–4 months. IOP normalized by 4 months
Gado and Macky (2014)^Citation31	Six-month, RCT, eyes with perfused CRVO with ME	60 (30 in each group)	0.7 mg DEX implant versus PRN bevacizumab	BCVA change between the groups	Monthly for six months	No difference in BCVA between the two groups. Bevacizumab group had thinner CST at one month, no difference thereafter	Higher IOP in DEX group. All eyes in DEX group needed second implant around 4 months. Mean 4.3 injections in bevacizumab group
Hoerauf et al. (2016) COMRADE-C^Citation32	Six-month RCT, RZB versus DEX implant for ME secondary to CRVO	124 RZB, 119 DEX	Monthly RZB for three months followed by PRN versus single DEX implant	Change in BCVA	Monthly for six months	No difference in BCVA at month 1 and 2. RZB superior from month 3–6. +12.86 letters in RZB, +3 in DEX at 6 months	4.52 injections in RZB versus single in DEX
Hattenbach et al. (2018) COMRADE-B^Citation33	Six-month RCT, RZB versus DEX implant for ME secondary to BRVO	126 RZB, 118 DEX	Monthly RZB for three months followed by PRN versus single DEX implant	Change in BCVA	Monthly for six months	No difference in BCVA at month 1 and 2. RZB superior from month 3–6. +17.3 letters in RZB, +9.2 in DEX at 6 months	4.68 RZB injections versus single DEX
Bandello et al. (2018)^Citation34	Twelve-month RCT, DEX v RZB in ME caused by BRVO	DEX 154, RZB 153	DEX at baseline and 5 months, optional at month 10 or 11, RZB 5 monthly injections followed by PRN	Change in BCVA	12 months	+7.4 letters in DEX, +17.4 in RZB at 12 months	2.5 DEX v 8 RZB injections. RZB superior to DEX regarding visual outcomes
Chatziralli et al. (2017) RANIDEX^Citation35	Retrospective Chart review, RZB v DEX for ME from CRVO	RZB 25, DEX 17	RZB, or DEX monotherapy	Change in BCVA and CST	Various time points over one year	CST. RZB superior at month 5 and 6. No difference at month 12 BCVA. +8.4 letters in RZB and +6.9 in DEX (NS)	5.1 injections in RZB, 2.1 in DEX. RZB group was likely undertreated
Gu et al. (2017)^Citation36	Six-month retrospective comparative Study. RZB v DEX for ME from RVO	RZB 32, DEX 32	RZB, or DEX monotherapy	BCVA and CST	Various time points up to six months	No difference between DEX and RZB	Only 3.4 and 3.5 injections of RZB in CRVO and BRVO respectively, likely undertreatment
Yuksel et al. (2018)^Citation37	Retrospective study. RZB v DEX. ME from BRVO	44 eyes. RZB 14, DEX 15, Laser 15	RZB, DEX, or laser	BCVA change, percent gaining ≥10 letters, and CST	6 months	No difference at six months in all three groups. +13.5 letters DEX, +7.1 RZB	Only 2.4 injections of RZB over 14 months, likely undertreatment
De Salles et al. (2021)^Citation38	Retrospective study of eyes with ME from RVO	492	Anti-VEGF versus DEX	BCVA and CST change	Final follow-up (variable time)	Superior visual and anatomical gains in anti-VEGF group for both BRVO and CRVO	Patients received about 4.5 anti-VEGF injections, and 1.8 DEX injections annually
Gale et al. (2021)^Citation39	Retrospective study of BRVO ME patients	5661	Laser, anti-VEGF or DEX implant	Change in BCVA	Up to 3 years	Anti-VEGF superior to DEX at 12 and 18 months. (+9.6 v +4.5 letters)	5.1 anti-VEGF v 1.5 DEX injections at 12 months.
Gale et al. (2021)^Citation40	Retrospective study of CRVO ME patients	4626	Anti-VEGF or DEX implant	Change in BCVA	12, 18 and 36 months	Anti-VEGF superior to DEX at all time points (+10 v +8.4 letters at 12 months, +10.4 v +1.6 at 18 month, +11.5 v +5.7 at 36 months)	Injections at 12 months (anti-VEGF/DEX)=5.6/1.6 At 18 months. 6/1.7 At 36 months 7/1.8 Higher endophthalmitis in DEX (0.09%) v anti-VEGF (0.003%)
Manoursaridis et al. (2017)^Citation41	Retrospective chart review of RZB resistant ME secondary to RVO switched to DEX implant	11	Single DEX implant for eyes resistant to ≥3 RZB injections	Change in BCVA and CST	Various time points up to 6 months	0.2 logMAR gain at 2 and 3 months. Return to baseline by month 6. CST improvement mainly at 2 and 3 months	DEX implant was effective in RZB resistant eyes for about 3 months
Georgalas et al. (2019)^Citation42	Prospective nonrandomized. Switch to DEX for persistent ME from RVO after ≥ 5 anti-VEGF injections	23 (13 BRVO, 10 CRVO)	DEX implant baseline, repeated as needed at six month	Change in BCVA and CST	2,4,6,8,10 and 12 month visits	BRVO. Best VA at 4 months after first and second injections. CRVO. Best VA and CST at 2 months after first and second injections	Reinjections sooner than 6 months are needed especially in CRVO
Mayer et al. (2012)^Citation43	Prospective, consecutive, nonrandomized	64	38 DEX, 26 3 monthly BCB followed by DEX	BCVA and CST change.	6 months	No benefit from BCB loading	Recurrence of ME 3–4 months after DEX injection in various groups
Singer et al. (2012)^Citation44	Prospective, nonrandomized	34	BCB followed 2 weeks later by DEX, retreatment as needed with same regimen	Time to reinject, BCVA gain, CST change	Monthly visits up to six months	+16.8 letter BCVA gain at six months, 64% gained ≥15 letters at six months	Retreatment in 82% at a mean of 126 days. No comparison group
Maturi et al. (2014)^Citation45	Prospective randomized	30	BCB monotherapy PRN versus PRN BCB+ single DEX one week later. Repeat DEX at 4 months PRN	Primary: Change in BCVA Secondary: CST, number of injections	6 months	No difference in BCVA, Fewer BCB (2 versus 3) and greater CST reduction in combination group,	The primary endpoint was not met. One less BCB injection in combination group balanced by DEX injection
Giuffre et al. (2020)^Citation46	Prospective, nonrandomized. ME secondary to RVO unresponsive to aflibercept and DEX monotherapies	30	Same day DEX+ aflibercept. Retreatment allowed after 4 months	BCVA and CST changes	12 months	No change in BCVA but CST reduction by 226 microns at 12 months.	Good anatomical response but not visual. Mean duration of ME was 25 months prior to combination therapy.
Harb et al. (2021)^Citation47	Prospective nonrandomized	74	DEX monotherapy versus Aflibercept followed by DEX two weeks later combination	BCVA and CST change, number of retreatments	12 months	Better BCVA gain in combination group compared to DEX monotherapy	No difference in CST or number of retreatments between the groups. Superior BCVA gain in combination group is hard to explain.
Bezatis et al. (2013)^Citation48	Retrospective, noncomparative	102	Single DEX implant for ME from RVO	BCVA and CST change	Up to 6 months	Peak effect at two months (about 0.3 logMAR gain)	Retreatment in 50% around 4 months
Korobelnik et al. (2016) LOUVRE^Citation49	Prospective, multicenter, real-world study in France	375	DEX monotherapy at baseline, retreatment at physician’s discretion	Primary. Change in BCVA Secondary. Other therapies, side effects, IOP	2 years	At 6 months: DEX +5.5, DEX + other therapies +4.2 letters. At 2 yrs: DEX: +20.7 single DEX, +4.9 multiple DEX, +2.3 DEX plus others	2.6 DEX injections over two years. Mean interval 6.6 months between injections, 55% received other therapy (laser or anti-VEGF). Cataract progression in 40%, increased IOP in 34.4%. Switch to other therapies did not improve outcomes
Capone et al. (2014) SHASTA^Citation50	Retrospective, multicenter chart review	289	DEX implant at baseline, other therapies per physician's discretion	Change in BCVA, CST, side effects	Variable (3–6 months after last DEX)	Peak change in BCVA from 4–20 weeks after DEX +1 line. 60% BRVO and 66% CRVO gained ≥2 lines	Mean reinjection interval 5.6 months, Increased IOP (≥10) in 32.6%. DEX monotherapy in 29.1%, adjunctive therapy in others
Eter et al. (2017)^Citation52	Prospective, multi-center, real-world, Germany	573	Single DEX at baseline. Additional treatment per physician's discretion	Change in BCVA at 12 weeks	12 weeks. Duration of study 6 months	At 12 weeks, +7.8 letters gain, 34% gained ≥3 lines.	≤90 days duration of ME had the best visual outcomes. 19.9% received other adjunctive treatments
Horner et al. (2020)^Citation53	Retrospective, real-world, single site, UK	66	Initial RZB, later DEX/laser	Change in BCVA and CST	Year 1 and 3	40% gained ≥3 lines at year 3	Diminished need for injections in year 3 compared to year 1 (2.5 v 5.5)
Kim et al. (2021)^Citation54	Prospective, multicenter, real-world, S Korea	700	DEX implant at baseline. Subsequent treatment per physician's discretion	Change in BCVA, responder rate, side effects	Month 1, 2, 4 and 6	Peak benefit at 2 months (approx. 2 lines).	Better vision gains in younger patients, worse presenting vision and treatment naïve status
Garay-Aramburu et al. (2021)^Citation55	Retrospective, short-term, real-world study	111	DEX implant at baseline	Visual and anatomical improvement	Unspecified	Worse presenting vision (<60 ETDRS letters), first injection, and non-chronic ME predictor of better visual outcomes.	Baseline CST ≥400 microns and central macular volume >12 mm^3 predictors of ≥50% CST reduction

Abbreviations: RVO, retinal vein occlusion; RCT, randomized controlled trial; BCVA, best-corrected visual acuity; IOP, intraocular pressure; ME, macular edema; CRVO, central retinal vein occlusion; CST, central subfield thickness; BCB, bevacizumab; RZB, ranibizumab; BRVO, branch retinal vein occlusion; NS, non-significant; VEGF, vascular endothelial growth factor.

Figure 2 (A) Persistent macular edema in an eye with superotemporal branch retinal vein occlusion despite 9 intravitreal bevacizumab, 17 ranibizumab, and 3 grid laser treatments over 61 months. (B) Resolution of macular edema one month after DEX implant.

Figure 3 (A) Fundus photo of an eye with intermediate uveitis showing marked vitreous haze and membranes. (B) Marked macular edema and subretinal fluid on OCT. (C) Three days after DEX implant showing marked improvement in vitreous haze and membranes. (D) Resolution of macular edema.

Table 2 Summary of Studies of DEX Implant in Uveitis and Uveitic Macular Edema

Study (Year)	Design	n	Intervention	Outcome Measure(s)	Time Point(s)	Results	Comments
Lowder et al. (2011) The HURON Study Group^Citation69	26-week, sham-controlled RCT	229 eyes with noninfectious posterior or intermediate uveitis	Single injection of DEX implant (350 mcg or 700 mcg) versus sham	Eyes with vitreous haze score of 0	8 weeks	47% with DEX 0.7, 36% with DEX 0.35, 12% sham achieved primary end point. Visual benefit persisted through week 26. CST benefit at 8 weeks, but not at 26	Superior visual results in DEX treated eyes at all visits. IOP≥25 mm Hg in 7.1% DEX 0.7, 8.7% DEX 0.35 and 4.2% for sham.
Pelegrin et al. (2015)^Citation70	Retrospective	42 eyes of 32 patients with UME	DEX implant, retreatment as needed	BCVA, CST reduction, side effects	Variable	Peak CST reduction at 1 month. Peak VA benefit at 3 months. No difference between vitrectomized and nonvitrectomized eyes	45.2% needed reinjection after a median of 5 months. Ocular hypertension in 47.6%.
Tsang et al. (2017)^Citation71	Retrospective	25 eyes of 15 patients with UME	DEX implant, repeated as needed	Primary CST, secondary BCVA, time to reinjection	Variable	91.4% had reduction in CST (−220 microns at 3 months). Approx 2 line VA gain at 3 months	11 patients on concurrent immunesuppression. No difference in effect between first implant and repeat implant.
Khurana et al. (2017)^Citation10	Prospective, noncomparative, single center	10 eyes with UME and quiescent uveitis	DEX implant at baseline, retreatment as needed after day 90	BCVA, CST	Day 90, and one year	+14.4 letter gain, and −140 microns CST reduction at 3 months.	60% needed retreatment. Visual and anatomical benefits maintained through one year with retreatments.
Nobre-Cardoso et al. (2017)^Citation72	Retrospective	41 eyes of 31 patients with UME	DEX implant at baseline, retreatment as needed	BCVA, CST, complications	Variable	At one month, CST improved in most eyes, but 31.7% shows no improvement in VA	Ocular hypertension in 36.2%. Small and short-term effect of DEX implant.
Fabiani et al. (2017)^Citation73	Retrospective	22 eyes with UME	Single DEX implant	Systemic steroid sparing effect	3 and six months	Reduced dose of systemic prednisone at 3 and 6 months. CST and BCVA improved at 1,3, and 6 month visits.	13.6% developed ocular hypertension. Returned to baseline by 6 months.
Ratra et al. (2018)^Citation74	Retrospective	42 eyes of 34 patients with UME	DEX implant as needed	BCVA, CST	Variable	Visual, anatomical and steroid sparing effect of DEX implant. 10 eyes (24%) needed no other treatment. Oral steroids stopped in 40%	Only 11 eyes (26%) needed repeat injection after 12.6–20.9 months. Prolonged effect of DEX implant hard to explain.
Thorne et al. (2019) The POINT Trial^Citation75	Six month, multicenter, randomized, clinical trial	235 eyes of 192 patients with UME	PTA (40 mg), IVTA (4mg), DEX (0.7 mg)1:1:1 randomization. Retreatment permitted at 8 weeks in PTA and IVTA, and at 12 weeks in DEX	CST, BCVA, side effects	CST at 8 weeks. BCVA and IOP over six months	Both IVTA and DEX superior to PTA regarding CST reduction and BCVA, DEX noninferior to IVTA. Repeat injection 38 (48%) IVTA, 44 (56%) DEX.	Higher IOP in intravitreal groups compared to PTA, no difference between DEX and IVTA.

Abbreviations: UME, uveitic macular edema; PTA, periocular triamcinolone acetonide; IVTA, intravitreal triamcinolone acetonide; CST, central subfield thickness.

Table 3 Summary of Studies of DEX Implant in Diabetic Macular Edema

Study (Year)	Design	n	Intervention	Outcome Measure(s)	Time Point(s)	Results	Comments
Haller JA et al. (2010)^Citation83	Sham-controlled RCT	171	Single injection DEX 0.7 mg, DEX 0.35 mg, or sham	≥10 letter BCVA gain	90 and 180 days	Day 90. Gainers 33.3% DEX 0.7, 21.1% DEX 0.35 Day 180. Gainers 30% DEX 0.7, 19% DEX 0.35	Phase II study
Pacella et al. (2013)^Citation84	Prospective, nonrandomized, interventional	20 eyes of 17 patients	Single DEX implant	BCVA and CST change	Various time points over 6 months	BCVA and CST gain from 3^rd day until 3 months. (−.14 logMAR, −226 microns at 3 months)	Regression of BCVA and CST at month 4 and 6. Two eyes re-injected prior to six months
Callanan et al. (2013) PLACID^Citation93	RCT	253 eyes with diffuse DME	Combination. DEX baseline laser 1 month monotherapy. Sham baseline laser 1 month. Up to 3 additional laser and one DEX permitted	BCVA (≥ 10 letter gain) and area of vascular leakage by angiography.	12 months	Combination group better at 1 and 9 months, but no difference at 12 months	DEX implant offered no visual benefit to focal laser alone at 12 months. Combinatin group had greater decrease in vascular leakage area
Lazic et al. (2014)^Citation85	Prospective, nonrandomized, interventional	16 eyes of 15 patients	Single DEX, eyes with “unresponsive” DME after ≥3 monthly anti-VEGF injections	BCVA and CST change	Monthly for six months	Peak VA gain at 2 months, CST improvement at 1,2,3 months	Increased IOP at 1,2,3 months. Duration of therapeutic effect 3–4 months.
Boyer et al. (2011)^Citation86	Prospective, nonrandomized, interventional	55 eyes with DME and history of prior PPV	Single DEX implant	Primary: Change in CST and Secondary: change in BCVA	Week 8 and 26	Week 8. −156 micron CST, +6 letters BCVA Week 26. −65 microns CST, +3 letters BCVA	30% gained ≥10 letters at week 8
Medeiros et al. (2014)^Citation87	Retrospective, comparative	58 eyes. 24 vitrectomized, 34 nonvitrectomized	Single DEX	BCVA and CST	Month 1, 3, 6	Improved BCVA and CST at each visit.	No difference between vitrectomized and nonvitrectomized eyes
Medeiros et al. (2014)^Citation101	Retrospective, noncomparative	58 eyes with “refractory” DME	Single DEX	BCVA and CST	Month 1, 3, 6	Reduction in CST at 1 and 3 month, some regression at month 6. Peak VA benefit at 3 months (about 2 lines)	Refractory not defined.
Boyer et al. (2014) The MEAD Study^Citation82	3-year, sham-controlled RCT	1048	1:1:1 randomization DEX 0.7 mg, DEX 0.35 mg, sham. Retreatment allowed ≥ 6 months	≥ 15 letter BCVA gain, CST	3 years	Gainers: 22.2% (DEX 0.7), 18.4% (DEX 0.35) and 12% (sham). Mean CST reduction −111.6 microns (DEX 0.7), −107.9 (DEX 0.35), −41.9 (sham)	Cataract 67.9% phakic eyes (DEX 0.7), 64% (DEX 0.35). IOP elevation in about 25%, Overall mean improvement in BCVA only 3 to 4 letters
Maturi et al. (2015)^Citation97	RCT	40 eyes with “incomplete response to anti-VEGF injections”	BCB monotherapy versus combination (BCB baseline, DEX at month 1, and 5.9 PRN)	Change in BCVA, and CST	12 months	Similar BCVA gain in both groups (+4.9 v +5.4 letters), Greater CST reduction in CST group (−45 microns v −30 microns)	3 fewer BCB injections in combination group but required 2.1 DEX injections (no real benefit)
Totan et al. (2016)^Citation102	Prospective, interventional, nonrandomized (Switch study)	30	Single DEX for eyes “resistant” to prior BCB	Change in BCVA and CST	1, 3, and 6 months	BCVA gain at 1 and 3 months (about −0.14 logMAR), Improved CST at all three time points	Regression of effect between 3 and 6 months.
Shah S et al. (2016)^Citation103	RCT	50	DEX q 3 months, v BCB monotherapy for persistent DME despite ≥3 anti-VEGF injections within 5 months	BCVA, CST reduction	7 months	Similar BCVA gain (BCB +5.6, DEX +5.8 letters), greater CST reduction in DEX (−122 v −13 microns)	Eyes with “persistent” DME show improvement in vision with continued anti-VEGF injections
Chhablani et al. (2016)^Citation90	Retrospective, comparative	79 eyes (15 treatment naïve, 64 previously treated “recalcitrant”)	DEX at baseline, repeated as needed	BCVA, CST	Variable	Similar BCVA gain in both groups (about 0.15 logMAR)	“Real-life” study. Reinjection after mean 6.5 months
Callanan et al. (2017)^Citation94	RCT, multi-center, noninferiority	DEX 181, RZB 182	DEX every 5 months, versus RZB monthly PRN	BCVA, CST, percentage gainer ≥15 letters	12 months	DEX +4.34, RZB +7.6 letters	DEX noninferior to RZB, greater decrease in fluorescein leakage area in DEX group
Castro-Navarro et al. (2019)^Citation89	Retrospective, comparative	84 eyes (29 treatment naïve and 55 previously treated “refractory”)	Single DEX implant	BCVA, CST	2, 4 and 6 months	Similar CST improvement in both groups. Naïve eyes more likely than treated eyes to gain ≥10 letters	“Refractory” not defined.
Maturi et al. (2018) DRCR.net Protocol U^Citation99	Six-month, multicenter, RCT	236 patients with persistent DME despite ≥ 3 anti-VEGF injections over the previous 20 weeks enrolled. All given RZB every month for 3 more injections. Those with still persistent DME (n=129) were randomized.	Combination: DEX every 3 months plus monthly RZB v monthly RZB monotherapy	BCVA gain, proportion of eyes gaining ≥15 letters, CST change	24 weeks	No difference in BCVA gain (+3 letters) between the two groups. 11% v 2% gained ≥15 letters in combination v monotherapy respectively. Greater CST reduction in combination v monotherapy (110 μm v 62 μm)	30% developed increased IOP in combination group. No BCVA benefit from combination either in phakic or pseudophakic eyes (subgroup analysis). No difference between short duration (6 months) or longer duration of DME

Abbreviations: BCB, bevacizumab; PPV, pars plana vitrectomy; RZB, ranibizumab.

Figure 4 (A) Diabetic macular edema persistent after 10 intravitreal bevacizumab and 13 aflibercept injections over 40 months. (B) Resolution of macular edema one month after DEX implant.

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